Role & responsibilities

Engineering QMS Key Responsibilities
Prepare, review, revise, and maintain Engineering SOPs, formats, work instructions, and policies.
Ensure timely document review, revision, and compliance with QMS requirements.
Initiate and investigate engineering deviations, perform RCA, and implement CAPA.
Coordinate engineering Change Control activities and ensure timely closure.
Prepare/review DQ, IQ, OQ, PQ protocols and reports.
Support qualification and requalification of utilities, equipment, and HVAC systems.
Monitor preventive maintenance and calibration schedules and maintain records.
Participate in internal, customer, and regulatory audits and ensure timely closure of observations.
Maintain engineering logbooks, maintenance, breakdown, and utility records.




Conduct QMS/GMP training and maintain training and competency records.
Perform Quality Risk Management (QRM) and support risk mitigation activities.
Ensure PM, calibration, documentation, deviation, CAPA, and Change Control compliance.
Prepare engineering indents and coordinate with Procurement and Engineering teams to resolve related issues.

Preferred candidate profile

Valuable knowledge of cGMP, Schedule M, WHO-GMP, and regulatory requirements.

Deviations, CAPA, change control, and document management.

Knowledge of qualification and validation activities.

Solid documentation and communication skills.

Proficiency in Microsoft Office and electronic QMS systems.

📌 Engineering Qms Mumbai
🏢 Yashraj Biotechnology
📍 Mumbai